Influenza Vaccine in HIV Study
December 15, 2015 updated by: Prof Stephen Kent, University of Melbourne
A Comparison of Immune Responses to the Licensed Trivalent Inactivated Influenza Vaccine in HIV-positive and HIV-negative Subjects
The aims of this study are:
- to investigate if HIV infection alters the antibody responses to influenza and
- to assess the ability of licensed influenza vaccine to induce functional non-neutralising antibodies in HIV-infected and HIV-uninfected subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
57
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects are recruited from two sites in Melbourne, Australia:
- Melbourne Sexual Health Centre (HIV-positive and HIV-negative subjects)
- The University of Melbourne at the Peter Doherty Institute for Infection and Immunity (HIV-negative subjects only)
Description
Inclusion Criteria:
- HIV-1 positive by licensed diagnostic test (for HIV-positive group only)
- Planning to receive the seasonal influenza vaccine outside the study
- Provision of written informed consent
Exclusion Criteria:
- Previous allergy to influenza vaccination
- Pregnancy or planning to become pregnant
- Unwilling or unable to provide blood samples
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
HIV-negative
|
Subjects received licensed influenza vaccine (Fluvax®), 1ml intramuscular injection.
|
|
HIV-positive
|
Subjects received licensed influenza vaccine (Fluvax®), 1ml intramuscular injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Anti-influenza antibody responses in plasma with Fc-mediated functions
Time Frame: Four weeks after influenza vaccination
|
Four weeks after influenza vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen Kent, Professor, University of Melbourne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
December 14, 2015
First Submitted That Met QC Criteria
December 15, 2015
First Posted (Estimate)
December 16, 2015
Study Record Updates
Last Update Posted (Estimate)
December 16, 2015
Last Update Submitted That Met QC Criteria
December 15, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kent001
- AISRF08020 (Other Grant/Funding Number: The Australia-India Strategic Research Fund)
- 1041832, 1042634, 1052979 (Other Grant/Funding Number: The Australian National Health and Medical Research Council)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.